End Stage Kidney Disease (ESKD)NCT07911969
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
A study testing Culinary Medicine Intervention and Pre-prepared MTMs in people with End Stage Kidney Disease (ESKD), run by Baylor College of Medicine.
Trial summary
End-Stage Kidney Disease (ESKD) in children is a severe and irreversible condition that significantly impacts their growth, development, and overall quality of life. Children with ESKD often face numerous physical, emotional, and social challenges, including the need for life-saving dialysis or kidney transplantation. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- End Stage Kidney Disease (ESKD)
- What is being tested?
- Culinary Medicine Intervention and Pre-prepared MTMs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged between 10 and 17 years receiving chronic outpatient dialysis- hemodialysis or peritoneal dialysis at Texas Children's Hospital;
- Patients have been receiving chronic outpatient dialysis for at least 3 months to ensure a stable dialysis prescription and dry weight assessment;
- Patients who receive more than 80% of their feeds by mouth and can provide feedback on the taste;
- Ability of the parent to speak and read in English or Spanish.
Who cannot join
- Children who have been receiving chronic dialysis for less than 3 months;
- Children with severe developmental delay that could affect the ability to communicate;
- those who are tube-fed or receive their nutrition predominantly tube or intravenous means;
- Children in foster-care;
- Children scheduled to receive a living donor kidney transplant in 3 months or less;
- Children with significant co-morbidities including active malignancies and organ transplantation;
- Children or family participating in any other food is medicine initiative (food/produce prescription, MTMs, etc.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
End-Stage Kidney Disease (ESKD) in children is a severe and irreversible condition that significantly impacts their growth, development, and overall quality of life. Children with ESKD often face numerous physical, emotional, and social challenges, including the need for life-saving dialysis or kidney transplantation. Despite advancements in clinical management, dietary adherence remains a critical component in managing ESKD and improving health outcomes. This study will compare two approaches to providing medically tailored meals (MTMs) for children with ESKD. A total of 30 children and their parents or caregivers will be randomly assigned to one of two groups: (1) a culinary medicine program that teaches families how to plan, shop for, and prepare kidney-friendly meals at home, or (2) a program that provides pre-prepared, kidney-friendly meals delivered to their homes. The study will assess how practical and acceptable each approach is for families and examine its potential effects on children's health and dietary habits. Researchers will evaluate participation, satisfaction, and study completion rates. They will also examine changes in children's blood potassium and phosphorus levels, blood pressure, fluid balance, diet quality, and health-related quality of life. In addition, the study will explore whether the culinary medicine program improves parents' nutrition knowledge, confidence in preparing healthy meals, meal planning, grocery shopping, cooking skills, and availability of healthy foods at home. Researchers will also compare the costs of the two approaches, including food, educational materials, and staff time, to estimate the cost per child. The findings will help determine whether these approaches are practical for families and provide information to guide future studies and programs to improve nutrition and health among children with ESKD.
Read the detailed description
Children with end-stage kidney disease (ESKD) require careful dietary management to maintain appropriate potassium and phosphorus levels, control blood pressure, manage fluid balance, and support growth and development. However, following a kidney-friendly diet can be challenging for children and their families because of complex dietary restrictions, food preferences, limited nutrition knowledge, cooking skills, time constraints, and food access barriers. These challenges may affect dietary adherence, clinical outcomes, and health-related quality of life.
Medically tailored meals (MTMs) are meals designed to meet the specific nutritional needs of individuals with chronic health conditions. Although MTMs have shown promising results in improving dietary and health outcomes among adults with chronic diseases, limited research has examined their feasibility and effectiveness among children with ESKD. In addition, little is known about whether providing pre-prepared meals or teaching families to prepare medically tailored meals is a more feasible, acceptable, and sustainable approach.
This study will use a two-arm randomized design to compare two MTM delivery strategies among children with ESKD receiving care at Texas Children's Hospital. The first approach uses culinary medicine (CM), which combines nutrition education with practical food preparation skills to help parents and caregivers plan, shop for, and prepare meals that meet their child's dietary needs. The second approach provides home-delivered, pre-prepared MTMs designed to meet the child's nutritional requirements. Both approaches aim to support dietary management but differ in the level of family involvement, convenience, and skills development.
Thirty parent-child dyads will be randomly assigned to either the CM-based MTM intervention (n=15) or the home-delivered, pre-prepared MTM intervention (n=15). The primary focus will be to assess the feasibility and acceptability of both approaches, including recruitment, intervention participation, retention, satisfaction, and data collection procedures. Post-intervention interviews will provide additional information about participants' experiences, perceived benefits, challenges, and suggestions for improvement.
The study will also explore the preliminary effects of both interventions on children's clinical and dietary outcomes. Clinical outcomes will be examined in relation to participants' historical electronic medical record (EMR) data. Comparisons between intervention groups will explore potential differences in children's diet quality and health-related quality of life.
Additional exploratory analyses will examine whether the CM-based approach leads to greater improvements in parents' food-related behaviors, including meal planning, grocery shopping, and cooking; psychosocial factors, including nutrition knowledge, self-efficacy, outcome expectations, perceived social norms, and social support; and the availability of healthy foods in the home.
Because this is a small preliminary study, analyses will focus on estimating the direction and magnitude of potential effects and variability in outcomes rather than establishing statistically significant differences between groups. Findings will help inform the design of a future larger trial.
The study will also assess the budget impact of implementing each MTM strategy. Program costs, including food, educational materials, and personnel time, will be documented to estimate the intervention cost per child and compare resource requirements between approaches.
Overall, this study will provide preliminary evidence on the feasibility, acceptability, potential clinical benefits, and implementation costs of two MTM strategies for pediatric ESKD. Findings will inform future research and the potential integration of medically tailored nutrition interventions into routine pediatric kidney care.
- Conditions
- End Stage Kidney Disease (ESKD)
- Being tested
- Culinary Medicine Intervention, Pre-prepared MTMs
- Keywords
- ESKD, culinary medicine, medically tailored meals
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culinary Medicine InterventionBehavioural
Also called CM intervention
The intervention includes 12 weekly, 2-3 hour sessions (in-person or virtual based on participant preference and logistics). While some sessions may take place in home to facilitate hands-on cooking instruction and skill-building, others may be conducted virtually. Virtual sessions will be designed to replicate hands-on instruction guiding participants in real-time using video conferencing tools, offering step-by-step guidance, observing technique, and providing feedback throughout the cooking process. Sessions will focus on patient-centered communication, culinary skills, meal preparation for children with ESKD, self-efficacy building, and feedback. Each family will receive a cooking kit and groceries tailored to dietary needs.
Pre-prepared MTMsBehavioural
During the 12-week intervention, children in this arm will receive weekly delivery of 14 fully prepared, refrigerated and/or frozen meals (7 lunches, 7 dinners). They will also receive educational materials and resources to help align family meals with the child's dietary requirements, making it easier to manage meal preparation. HFB will also work with the participants to address any barriers related to delivery schedules.
| Study group | Role | What they receive |
|---|---|---|
| Culinary medicine | Experimental | Participants in this arm will receive the culinary medicine intervention, led by a Chef-RD from UTHealth Nourish program. Receives: Behavioral: Culinary Medicine Intervention |
| Pre-prepared MTMs | Experimental | Participants in this arm will receive weekly MTM renal-supportive meals from the Houston Food Bank. Renal-supportive meals suitable for pediatric patients with ESKD under medical supervision and designed with the guidelines of the National Kidney Foundation will be provided. Receives: Behavioral: Pre-prepared MTMs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment
Recruitment feasibility will be assessed by staff logs. Records will include number of families contacted, the number who qualified; the number who did not qualify and the reasons; and of those who qualified - number who agreed to participate; the number who did not participate and reasons; and the number who completed and return enrollment package and were enrolled.
CRITERION: recruitment goals are met (n=30 parent-child dyads). Investigators will determine if this criterion was met by comparing the number of families enrolled to the criterion.
Measured: through study completion, an average of 1 year
Feasibility - Participation in intervention activities
Participation in intervention activities will be assessed through REDCap surveys. Culinary medicine (CM) participants will receive weekly text messages linking to surveys assessing session attendance, activity participation, and meal feedback. Participants receiving pre-prepared medically tailored meals (MTMs) will scan QR codes on meal boxes to complete meal-specific feedback surveys. Pre- and post-meal photographs will help estimate meal consumption and assess intervention adherence.
Criteria: CM participants will achieve ≥75% adherence to intervention activities, calculated as the average number of activities completed divided by the total activities offered, based on session logs and participant feedback. For the pre-prepared MTM group, the target is consumption of ≥70% of meals provided by the enrolled child, assessed through participant feedback and meal photographs.
Measured: up to 12 weeks of intervention
Feasibility - Attrition
Attrition rate is defined as the number of participants who did not complete the intervention (i.e. weekly CM sessions and MTMs) and all data collection activities (i.e. baseline, post intervention). It will be calculated by dividing the total number of participants who completed these activities by the total number providing informed consent.
CRITERION: overall attrition rate is <10%. Investigators will determine if this criterion was met by dividing the number of families who completed all intervention and data collection activities by the total number of families enrolled and comparing the result to the criterion.
Measured: Baseline to 12 weeks
Acceptability - Program satisfaction
Program satisfaction will be assessed at post intervention with a 10-item measure of satisfaction. Items will be rated using a 2-point Likert scale (no, yes). Scores can range from 10-20, with higher scores representing higher satisfaction.
CRITERION: >80% for both children and parents. Investigators will determine if this criterion was met by determining the average satisfaction score for parents and children separately and comparing the results to the criterion.
Measured: At 12 weeks from baseline
Feasibility - Data completeness
Data completeness is defined as the percentage of participants with complete self-report data at all assessment points (baseline, post intervention). These data will be obtained from the missing data in data files.
CRITERION: >80% of data are collected at baseline and post intervention. Investigators will determine if this criterion was met by calculating the number of families with complete data and comparing it to the criterion.
Measured: Baseline and at 12 weeks
Acceptability - Feedback interviews
Post intervention interviews with parents and children will seek to obtain a better understanding of the acceptability of the intervention, participants' experiences, preferences, and challenges encountered during the program.
Measured: At 12 weeks from baseline
Secondary outcomes (2)
Child's metabolic profile
The EMR will be queried to obtain laboratory results including serum sodium, potassium, phosphorus, parathyroid hormone (PTH) and protein catabolic rate (nPCR) performed monthly as standard of care in the outpatient dialysis unit. Blood pressure information will be collected weekly on a day where the patient has not received hemodialysis in 48 hours (for the HD cohort). Pre and post dialysis weights would be collected weekly on day where the patient has not received hemodialysis in 48 hours (HD cohort). Dry weights would also be collected to assess fluid overload. Medication lists will be reviewed and information on number of antihypertensive medications and use of short acting anti-hypertensive medication collected. Information on phosphate binder use will also be collected.
Measured: Up to 12 weeks from baseline
Diet quality
To assess usual dietary intake, investigators will obtain two 24-hour dietary recalls (1 week day; 1 weekend day) over the telephone at each data collection (baseline, post-intervention). Investigators will obtain the dietary recalls (24hdr) by telephone on non- consecutive days at each observation. Children 8 years and older can give a reasonably accurate self-report of intake, For younger children, parent-reported dietary recalls will be conducted to ensure data validity. Dietary intake data gathered by interview is governed by a multiple-pass interview approach. Multiple 24-hour dietary recalls are considered the gold-standard for dietary assessment, and in addition to the calories and servings consumed, will allow us to compute a Healthy Eating Index (HEI-2015), a measure of diet quality. The recalls will be collected by trained staff using Nutrition Data System for Research (NDS-R, 2019 version).
Measured: Baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The University of Texas Health Science Center, Houston, Houston Food Bank
- Responsible party
- Principal investigator, Jayna Dave, Baylor College of Medicine
- Investigators
- Jayna Dave, PhD, Principal investigator, Baylor College of MedicineElizabeth Onugha, MD, Principal investigator, Texas Children's Hospital; Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911969
- Sponsor's protocol ID
- H-57097
- Other IDs
- R01DK141577-01A1
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made publicly available due to the small sample size, sensitive clinical information, and potential risk of participant identification, particularly given the vulnerable pediatric population with end-stage kidney disease. Study findings will be disseminated through peer-reviewed publications and scientific presentations. Any requests for data sharing will be considered in accordance with institutional policies, participant consent, and applicable federal data-sharing requirements.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
- ClinicalTrials.gov ID
- NCT07911969
- Acronym / sponsor ID
- H-57097
- Conditions
- End Stage Kidney Disease (ESKD)
- Keywords
- ESKD, culinary medicine, medically tailored meals
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The University of Texas Health Science Center, Houston, Houston Food Bank
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
End-Stage Kidney Disease (ESKD) in children is a severe and irreversible condition that significantly impacts their growth, development, and overall quality of life. Children with ESKD often face numerous physical, emotional, and social challenges, including the need for life-saving dialysis or kidney transplantation. Despite advancements in clinical management, dietary adherence remains a critical component in managing ESKD and improving health outcomes. This study will compare two approaches to providing medically tailored meals (MTMs) for children with ESKD. A total of 30 children and their parents or caregivers will be randomly assigned to one of two groups: (1) a culinary medicine program that teaches families how to plan, shop for, and prepare kidney-friendly meals at home, or (2) a program that provides pre-prepared, kidney-friendly meals delivered to their homes. The study will assess how practical and acceptable each approach is for families and examine its potential effects on children's health and dietary habits. Researchers will evaluate participation, satisfaction, and study completion rates. They will also examine changes in children's blood potassium and phosphorus levels, blood pressure, fluid balance, diet quality, and health-related quality of life. In addition, the study will explore whether the culinary medicine program improves parents' nutrition knowledge, confidence in preparing healthy meals, meal planning, grocery shopping, cooking skills, and availability of healthy foods at home. Researchers will also compare the costs of the two approaches, including food, educational materials, and staff time, to estimate the cost per child. The findings will help determine whether these approaches are practical for families and provide information to guide future studies and programs to improve nutrition and health among children with ESKD.
Detailed description
Children with end-stage kidney disease (ESKD) require careful dietary management to maintain appropriate potassium and phosphorus levels, control blood pressure, manage fluid balance, and support growth and development. However, following a kidney-friendly diet can be challenging for children and their families because of complex dietary restrictions, food preferences, limited nutrition knowledge, cooking skills, time constraints, and food access barriers. These challenges may affect dietary adherence, clinical outcomes, and health-related quality of life.
Medically tailored meals (MTMs) are meals designed to meet the specific nutritional needs of individuals with chronic health conditions. Although MTMs have shown promising results in improving dietary and health outcomes among adults with chronic diseases, limited research has examined their feasibility and effectiveness among children with ESKD. In addition, little is known about whether providing pre-prepared meals or teaching families to prepare medically tailored meals is a more feasible, acceptable, and sustainable approach.
This study will use a two-arm randomized design to compare two MTM delivery strategies among children with ESKD receiving care at Texas Children's Hospital. The first approach uses culinary medicine (CM), which combines nutrition education with practical food preparation skills to help parents and caregivers plan, shop for, and prepare meals that meet their child's dietary needs. The second approach provides home-delivered, pre-prepared MTMs designed to meet the child's nutritional requirements. Both approaches aim to support dietary management but differ in the level of family involvement, convenience, and skills development.
Thirty parent-child dyads will be randomly assigned to either the CM-based MTM intervention (n=15) or the home-delivered, pre-prepared MTM intervention (n=15). The primary focus will be to assess the feasibility and acceptability of both approaches, including recruitment, intervention participation, retention, satisfaction, and data collection procedures. Post-intervention interviews will provide additional information about participants' experiences, perceived benefits, challenges, and suggestions for improvement.
The study will also explore the preliminary effects of both interventions on children's clinical and dietary outcomes. Clinical outcomes will be examined in relation to participants' historical electronic medical record (EMR) data. Comparisons between intervention groups will explore potential differences in children's diet quality and health-related quality of life.
Additional exploratory analyses will examine whether the CM-based approach leads to greater improvements in parents' food-related behaviors, including meal planning, grocery shopping, and cooking; psychosocial factors, including nutrition knowledge, self-efficacy, outcome expectations, perceived social norms, and social support; and the availability of healthy foods in the home.
Because this is a small preliminary study, analyses will focus on estimating the direction and magnitude of potential effects and variability in outcomes rather than establishing statistically significant differences between groups. Findings will help inform the design of a future larger trial.
The study will also assess the budget impact of implementing each MTM strategy. Program costs, including food, educational materials, and personnel time, will be documented to estimate the intervention cost per child and compare resource requirements between approaches.
Overall, this study will provide preliminary evidence on the feasibility, acceptability, potential clinical benefits, and implementation costs of two MTM strategies for pediatric ESKD. Findings will inform future research and the potential integration of medically tailored nutrition interventions into routine pediatric kidney care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culinary medicine | Experimental | Behavioral: Culinary Medicine InterventionParticipants in this arm will receive the culinary medicine intervention, led by a Chef-RD from UTHealth Nourish program. |
| Pre-prepared MTMs | Experimental | Behavioral: Pre-prepared MTMsParticipants in this arm will receive weekly MTM renal-supportive meals from the Houston Food Bank. Renal-supportive meals suitable for pediatric patients with ESKD under medical supervision and designed with the guidelines of the National Kidney Foundation will be provided. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients aged between 10 and 17 years receiving chronic outpatient dialysis- hemodialysis or peritoneal dialysis at Texas Children's Hospital;
- Patients have been receiving chronic outpatient dialysis for at least 3 months to ensure a stable dialysis prescription and dry weight assessment;
- Patients who receive more than 80% of their feeds by mouth and can provide feedback on the taste;
- Ability of the parent to speak and read in English or Spanish.
Key exclusion criteria (7 listed)
- Children who have been receiving chronic dialysis for less than 3 months;
- Children with severe developmental delay that could affect the ability to communicate;
- those who are tube-fed or receive their nutrition predominantly tube or intravenous means;
- Children in foster-care;
- Children scheduled to receive a living donor kidney transplant in 3 months or less;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culinary Medicine InterventionAlso: CM interventionThe intervention includes 12 weekly, 2-3 hour sessions (in-person or virtual based on participant preference and logistics). While some sessions may take place in home to facilitate hands-on cooking instruction and skill-building, others may be conducted virtually. Virtual sessions will be designed to replicate hands-on instruction guiding participants in real-time using video conferencing tools, offering step-by-step guidance, observing technique, and providing feedback throughout the cooking process. Sessions will focus on patient-centered communication, culinary skills, meal preparation for children with ESKD, self-efficacy building, and feedback. Each family will receive a cooking kit and groceries tailored to dietary needs. | Behavioural | Culinary medicine |
| Pre-prepared MTMsDuring the 12-week intervention, children in this arm will receive weekly delivery of 14 fully prepared, refrigerated and/or frozen meals (7 lunches, 7 dinners). They will also receive educational materials and resources to help align family meals with the child's dietary requirements, making it easier to manage meal preparation. HFB will also work with the participants to address any barriers related to delivery schedules. | Behavioural | Pre-prepared MTMs |
Primary outcome
Feasibility - Recruitment
Time frame: through study completion, an average of 1 year
Recruitment feasibility will be assessed by staff logs. Records will include number of families contacted, the number who qualified; the number who did not qualify and the reasons; and of those who qualified - number who agreed to participate; the number who did not participate and reasons; and the number who completed and return enrollment package and were enrolled. CRITERION: recruitment goals are met (n=30 parent-child dyads). Investigators will determine if this criterion was met by comparing the number of families enrolled to the criterion.
Feasibility - Participation in intervention activities
Time frame: up to 12 weeks of intervention
Participation in intervention activities will be assessed through REDCap surveys. Culinary medicine (CM) participants will receive weekly text messages linking to surveys assessing session attendance, activity participation, and meal feedback. Participants receiving pre-prepared medically tailored meals (MTMs) will scan QR codes on meal boxes to complete meal-specific feedback surveys. Pre- and post-meal photographs will help estimate meal consumption and assess intervention adherence. Criteria: CM participants will achieve ≥75% adherence to intervention activities, calculated as the average number of activities completed divided by the total activities offered, based on session logs and participant feedback. For the pre-prepared MTM group, the target is consumption of ≥70% of meals provided by the enrolled child, assessed through participant feedback and meal photographs.
Feasibility - Attrition
Time frame: Baseline to 12 weeks
Attrition rate is defined as the number of participants who did not complete the intervention (i.e. weekly CM sessions and MTMs) and all data collection activities (i.e. baseline, post intervention). It will be calculated by dividing the total number of participants who completed these activities by the total number providing informed consent. CRITERION: overall attrition rate is <10%. Investigators will determine if this criterion was met by dividing the number of families who completed all intervention and data collection activities by the total number of families enrolled and comparing the result to the criterion.
Acceptability - Program satisfaction
Time frame: At 12 weeks from baseline
Program satisfaction will be assessed at post intervention with a 10-item measure of satisfaction. Items will be rated using a 2-point Likert scale (no, yes). Scores can range from 10-20, with higher scores representing higher satisfaction. CRITERION: >80% for both children and parents. Investigators will determine if this criterion was met by determining the average satisfaction score for parents and children separately and comparing the results to the criterion.
Feasibility - Data completeness
Time frame: Baseline and at 12 weeks
Data completeness is defined as the percentage of participants with complete self-report data at all assessment points (baseline, post intervention). These data will be obtained from the missing data in data files. CRITERION: >80% of data are collected at baseline and post intervention. Investigators will determine if this criterion was met by calculating the number of families with complete data and comparing it to the criterion.
Acceptability - Feedback interviews
Time frame: At 12 weeks from baseline
Post intervention interviews with parents and children will seek to obtain a better understanding of the acceptability of the intervention, participants' experiences, preferences, and challenges encountered during the program.
2 secondary outcomes
Child's metabolic profile
Time frame: Up to 12 weeks from baseline
Diet quality
Time frame: Baseline and at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. IPD will not be made publicly available due to the small sample size, sensitive clinical information, and potential risk of participant identification, particularly given the vulnerable pediatric population with end-stage kidney disease. Study findings will be disseminated through peer-reviewed publications and scientific presentations. Any requests for data sharing will be considered in accordance with institutional policies, participant consent, and applicable federal data-sharing requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jayna Dave, PhD principal investigator
Baylor College of Medicine
Elizabeth Onugha, MD principal investigator
Texas Children's Hospital; Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Culinary Medicine Intervention and Pre-prepared MTMs in people with End Stage Kidney Disease (ESKD), run by Baylor College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mamie White, MS (713-798-0501, mawhite@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment (time frame: through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.